On September 9, 2022 Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, reported that the US Food & Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for its DUNP19 technology for the treatment of osteosarcoma (Press release, Radiopharm Theranostics, SEP 9, 2022, View Source [SID1234619598]).

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The RPD program is aimed at advancing development of drugs with the potential to treat serious, rare pediatric diseases.

RPD allows companies to receive a priority review voucher (PRV) from the FDA at the time a marketing authorization is granted. A PRV can be used by the Company to expedite approval, or can be transferred/sold to other companies for use in the same manner. The price of two recent examples of PRVs sales have ranged from US$105,0001 to US$110,0002.

Radiopharm signed an exclusive licensing agreement with University of California Los Angeles (UCLA) Technology Development Group (UCLA-TDG) for the promising LRRC15 antibody "DUNP19" in April 2022.

LRCC15 expression is produced by cancer cells and the surrounding tumour microenvironment, but not by healthy normal tissues, and LRRC15 production is very high in aggressive and treatmentresistant tumours.

While currently available antibodies for cancer treatment omit tumour micro-environment (TME) cells, such as stromal and immune cells, which comprise >50% of tumour masses, the DUNP19 antibody has a unique ability to effectively find, internalize and destroy both cancer-, and TME cells. DUNP19 is a first-in-class therapy thanks to its unique dual action tumour targeting and to its fast internalization.

Osteosarcoma is a type of bone cancer that primarily affects children, adolescents and young adults, with surgery and chemotherapy the only currently available treatments. As aggressive osteosarcoma has one of the highest expressions of LRRC15, it’s an ideal candidate for proof-of-concept testing.

Riccardo Canevari, CEO and Managing Director of RAD, said: "This is again excellent recognition of the work to date by Dr David Ulmert and his team and the potential for DUNP19 to make a significant difference to young patients in need. The RPD and associated PRV can be incredibly valuable and we look forward to progressing the DUNP19 program and eventually taking advantage of this."

On September 9, 2022, Brooklyn ImmunoTherapeutics, Inc., a Delaware corporation (the "Company"), reported that entered into a Master Services Agreement with Factor Bioscience Inc., a Delaware corporation ("Factor"), pursuant to which Factor has agreed to provide services to the Company as agreed between the Company and Factor and set forth in one or more work orders under such agreement (including the first work order thereunder, the "MSA") (Filing, 8-K, Brooklyn ImmunoTherapeutics, SEP 9, 2022, View Source [SID1234619574]). Under the MSA, Factor has agreed to provide the Company with mRNA cell engineering research support services, including access to certain facilities, equipment, materials and training, and the Company has agreed to pay Factor an initial fee of $5,000,000, payable in twelve equal monthly installments of $416,667. Following the initial 12-month period, the Company has agreed to pay Factor a monthly fee of $416,667 until such time as the first work order under the MSA is terminated.

The Company may terminate the first work under the MSA on or after the second anniversary of the date of the MSA, subject to providing Factor with 120 days’ prior notice. Factor may terminate such work order only on and after the fourth anniversary of the date of the MSA, subject to providing the Company with 120 days’ prior notice. The MSA contains customary confidentiality provisions and representations and warranties of the parties, and the MSA may be terminated by ether party upon 30 days’ prior notice, subject to any superseding termination provisions contained in a particular work order.

In connection with entering into the MSA, Factor’s subsidiary, Factor Bioscience Limited ("Factor Limited"), agreed to waive payment of $3,500,000 otherwise payable to it in October 2022 by the Company’s subsidiaries under the Company’s previously disclosed Exclusive License Agreement, dated April 26, 2021, by and among Factor Limited and the Company’s wholly owned subsidiaries, Novellus Therapeutics Limited and Brooklyn ImmunoTherapeutics LLC.

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On September 9, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported that Kristi Jones, Chief Executive Officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12 at 11:00 am ET(Press release, NexImmune, SEP 9, 2022, View Source [SID1234619370]).

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The webcast will be accessible on the Investor Relations page of NexImmune’s website at Events and Presentations | NexImmune, Inc. A replay of the presentation will be available at the same location for 30 days following the conference.

On September 9, 2022 CureLab Oncology , a clinical-stage, pre-IPO biotech company, reported the results of its ongoing ex-US clinical trial at this year’s meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) (Press release, CureLab Oncology, SEP 9, 2022, View Source [SID1234619360]). The trial is assessing an experimental DNA plasmid encoding the human protein, p62 (affectionately codenamed Elenagen), at the N.N. Alexandrov National Cancer Centre, one of the leading cancer centers in Eastern Europe.

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Platinum-resistant ovarian cancer (PROC) is one of the deadliest forms of ovarian cancer and has a very poor prognosis. The FDA approved other novel treatments for PROC based on statistically significant improvements for the delay of progression of the cancer, assessed by the increasing size of a primary tumor and/or the appearance of new metastatic lesions or growth of the existing ones; i.e., progression-free survival (PFS). A statistically significant prolongation of PFS was clearly demonstrated in the trial and continues to extend as the trial continues.

Summary of what CureLab Oncology is presenting at ESMO (Free ESMO Whitepaper) 2022
In the ex-US clinical trial, CureLab Oncology is assessing its experimental plasmid DNA therapeutic, Elenagen, for its ability to extend progression-free survival (PFS) in patients with PROC receiving standard chemotherapy, gemcitabine.
For all patients in the trial receiving the standard of care only, the disease progressed during the first year of observations, with 50% of patients progressing within 2.7 months.
In contrast, the disease did not progress at all for almost 40% of patients receiving the same gemcitabine in combination with weekly intramuscular injections of Elenagen.
In 50% of patients receiving standard of care only, the disease has progressed within 2.7 months, while the time to progression for 50% of patients in the "chemo plus Elenagen" group has increased to 7.2 months.
To date, no patient receiving Elenagen demonstrated any adverse event (AE) or significant adverse event (SAE) greater than grade 1, and all resolved quickly without impact.
So far, the longest PFS in the gemcitabine + Elenagen treatment group is 27 months (and continues to grow), while the disease has progressed in all patients in the gemcitabine-only group within less than 12 months.
"While our data on increasing progression-free survival are already statistically significant (P=0.01), it will take a little longer to reach a statistical significance on overall survival of the patients," said Professor Sergey Krasny, M.D., D.Sc., co-author of the ESMO (Free ESMO Whitepaper) presentation, and a medical director of the study. "However, so far, no single patient receiving gemcitabine alone has lived longer than 18 months, while over 50 percent of patients receiving gemcitabine and Elenagen live longer than that. Also of note is that no person who survived to live 18 months has died at this point in the study."

"Our presentation at ESMO (Free ESMO Whitepaper) 2022 is a great step forward compared to what we presented at ESMO (Free ESMO Whitepaper) 2021. Now, we are certain that Elenagen is increasing progression-free survival for platinum-resistant ovarian cancer patients in the trial," said Alexander Shneider, Ph.D., CEO of CureLab Oncology.

About Elenagen
CureLab’s lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In animal studies and Phase I/II human trials conducted ex-US, Elenagen demonstrated promise in reversing tumor grade, changing the tumor microenvironment, and enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation and stimulation of an immune response to the tumor.

On September 9, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that it will webcast its presentations at two investor conferences in September (Press release, Sana Biotechnology, SEP 9, 2022, View Source [SID1234619348]). The presentations will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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Sana will present at the Morgan Stanley 20th Annual Global Healthcare Conference at 2:55 p.m. ET on Tuesday, September 13, 2022.
Sana will present at the Jefferies Cell and Genetic Medicine Summit at 2:00 p.m. ET on Thursday, September 29, 2022.
The webcasts will be accessible on the Investor Relations page of Sana’s website at View Source A replay of each presentation will be available at the same location for 30 days following the corresponding conference.